Recall Z-0469-2007 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Mizuho USA, Inc.
Confirm Clearly Smart Pregnancy Test (Confirm Clearly Starter Kits, Product Code 30136 and Confirm Clearly Refills Kits, Product Code 30138) Note: (1) Confirm Clearly Starter Kits: When sold in the U.S., the product consists of a reader and two disposable test sticks; when sold in Canada, the product consists of a reader and one disposable test stick (2) Confirm Clearly Refills Kits: The refill c
| Date | Jan 5, 2007 (initiated Nov 17, 2006) |
| Status | Terminated |
| Reason | False positives-the firm has received a higher than expected rate of complaints regarding false-positive results. |
| Root cause | Other |
| Action | On November 14, 2006, Mizuho USA and SSL decided to cease further distribution of the product, and to contact SSL''s customers and ask them to return any unsold units. Mizuho USA informed SSL Americas by telephone. On November 21, 2006, SSL Americas sent Recall Notification Letters to each of its customers by US First Class, Certified, Return-receipt mail. The letter included a 'Fax Back' Notification to be use by the firm for recall effectiveness checks. |
| Quantity | 474,000 Kits |
| Distribution | Worldwide-USA and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060825 | MULTI-USE ELECTRONIC PREGNANCY TEST Mizuho USA, Inc., Jun 19, 2006 |